When the FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public hazards, including those recalls associated with an outbreak.
Food allergy has been referred to as the second wave of the allergy epidemic, asthma being the first.
Smiths Medical has amended an urgent medical device recall that it first issued in August for its Medfusion syringe pump model series 3500 and 4000.
Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the US Food and Drug Administration (FDA) for Priority Review.
Digital health firm HealthTap and Bupa, a health care provider that offers both insurance and medical services to millions around the world, are teaming up in a massive strategic partnership that could make “digital end-to-end” medical services a widespread reality, HealthTap CEO Ron Gutman stated in an early interview previewing the arrangement.
AstraZeneca still enjoys the perks of being first to market with its PARP inhibitor. Lynparza (olaparib) sales were $81 million from July to September, whereas net revenues were $16.8 million and $39.4 million for Clovis Oncology Inc.'s Rubraca (rucaparib) and Tesaro Inc.'s Zejula (niraparib), respectively.
Adapsyn Bioscience Inc., a biotechnology company focused on the discovery and development of novel medicines derived from evolved small molecule natural products, announced that it has completed a round of financing that was co-funded by Pfizer R&D Innovate and Genesys Capital. In addition, the company has announced a research collaboration with Pfizer Inc.
If 2017 was about ransomware attacks, 2018 will be about cyber attacks on the Internet of Things (aka medical devices).
Global Blood Therapeutics, Inc. (GBT) (GBT) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to voxelotor (previously called GBT440) for the treatment of sickle cell disease (SCD). Voxelotor is being developed as a disease-modifying therapy for SCD and previously received European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of SCD.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide
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